Electrode for stimulating and/or detecting muscle activity of a patient accessible through a body orifice

ABSTRACT

An electrode assembly for stimulating or detecting activity of muscles accessible through a body orifice includes a carrier member having contact elements electrically connected to a detecting or stimulation assembly and an elongated sheath member formed of a rigid insulating material and having a handle portion and an insertion portion. The insertion portion has electrical contact elements including contact lips extending outwardly from the insertion portion. The elongated sheath member is positioned on the carrier member so that the contact lips are in electrical contact with the contact elements of the carrier member and the contact lips project radially into the sheath member and are resiliently supported in an axial direction against the contact elements of the carrier member.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to an electrode for stimulating and/or detectingthe muscle activity of muscles or muscle groups of a patient which areaccessible through a body orifice, the electrode being provided with acarrier and at least two electrically conducting contacts which areconnectable by means of a cable to a stimulation and/or detectionapparatus.

2. Description of the Prior Art

A known electrode of this type is in the form of a vaginal electrode forstimulating and/or detecting the muscle activity of the pelvic floormuscles in women, in particular the sphincter of the urethra feminina.Incontinence problems in women can be treated in this way. Of course,with the use of such aids it is of great importance to practice goodhygiene, in order to prevent infection between patients. In the case ofthe known electrode for this purpose essentially two possibilities havebeen used hitherto. A first possibility is to disinfect or, ifnecessary, sterilize the electrode after each treatment. This isrelatively laborious and time-consuming. The second possibility is togive each patient her own electrode, but this calls for a highinvestment in electrodes. Besides, in this case extensive administrationis required, and cleansing of the electrodes is still necessary.

Objects of the Invention

The object of the invention is to provide an electrode of the typementioned in the preamble, in which the above-mentioned disadvantagesare eliminated in a simple, yet effective manner.

SUMMARY OF THE INVENTION

For this purpose, the electrode of the type mentioned in the preamble ischaracterized according to the invention in that the carrier is providedwith contact elements and in that a disposable, elongated sheath ofinsulating material is detachably connectable to the carrier, while thecontacts are situated on the outside of the sheath and are connected tothe contact elements when the sheath is fitted on the carrier.

In this way an electrode made up of two parts is obtained, the partcoming into contact with the body orifice being disposable after use, sothat disinfection or sterilization are no longer necessary. The partwhich is disposed of after use comprises a simple sheath of insulatingmaterial which can be mass-produced at very low cost. The other part,onto which the sheath is pushed, can be made sturdy, and is suitable foruse a number of times.

According to a preferred embodiment, the sheath is composed of a rigidplastic material and comprises a part which is adapted in shape to thebody orifice, and to which a handle is connected, the contacts beingfixed in the sheath and each having a contact lip in the interior of thesheath, which contact lips are in contact with the contact elements whenthe sheath is fitted on the carrier. An electrode which is easy tohandle in practice is obtained in this way.

According to an alternative embodiment, the carrier is made elongatedand is provided with a part which is of a shape adapted to the bodyorifice and has a handle connecting thereto, while the sheath is made ofa thin, flexible material.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is explained in greater detail below with reference to thedrawings, in which a number of examples of embodiments are shownschematically.

FIG. 1A is a side view, partially produced in cross-section, of a firstembodiment of the electrode according to the invention.

FIG. 1B is a side partially exploded view of an enlarged detail portionof FIG. 1A.

FIG. 2 is a top view of the electrode according to FIG. 1A.

FIG. 3 is a section along the line III--III from, FIG. 1A.

FIG. 4 is a schematically shown longitudinal section of a secondembodiment of the electrode according to the invention.

FIG. 5 shows a detail of FIG. 4 on a larger scale.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A-3 show an electrode 1 for stimulating and/or detecting muscleactivity of muscles or muscle groups of a patient which are accessiblethrough a body orifice. This electrode 1 is provided with a carrier core2, in this case in the form of an elongated element, and a sheath 3which is detachably connectable to the carrier core 2. The carrier core2 is made of, for example, rigid plastic material and bears on the oneend, illustrated in the enlarged detail in FIG. 1A, four contactelements 4 which are supported in a resilient manner in the axialdirection in the end of the carrier core 2, and only one of which can beseen in FIG. 1A. The contact elements 4 are connected by conductors (notshown) to a connector 5, which is situated on the other end of thecarrier core 2. A cable for connecting the electrode 1 to a stimulationand/or detection apparatus can be connected to the connector 5.

The sheath 3 is made of a rigid plastic material and comprises a part 6which is adapted in shape to the body orifice, in this case the vagina,and to which a handle 7 is connected, by means of which the electrode iseasy to handle and easy to insert into the body orifice. As shown in thecross-section of FIG. 3, four contacts 8 are fitted in the part 6 of thesheath 3, said contacts in this example projecting relative to theoutside surface of the sheath 3, so that a good contact with the skin isensured. The contacts 8 each have at their end a connecting lip 9, theselips projecting radially into the sheath 3 and being pressed against thecontact elements 4 when the sheath 3 is slid onto the carrier core 2.

As an alternative, the carrier core 2 can be made considerably shorter,in which case the contacts 8 of the sheath 3 are connected, for exampleby means of conductors incorporated in the sheath, to connecting lipswhich are fitted nearer to the open end of the sheath. Of course,differently designed contact elements and connecting lips are alsopossible.

The sheath 3 is composed of two elongated shell halves 10 and 11, ofwhich the top shell half 10 shown in FIG. 1A has recesses for thecontacts 8. The other shell half 11 has two clamping plates 12 which inthe assembled state of the sheath 3 fix the contacts 8 in the recessesof the shell half 10.

The carrier core 2 has at the end of the connector 5 a shut-off part 13of larger diameter which is accommodated in a close fit in the handle 7of the sheath 3. This shut-off part 13 bears a casing 14 which runs fromthe side situated opposite the contacts 8 approximately in a circulararc shape to the side where the contacts 8 are situated to a groove 15formed in the casing 14. The corresponding end of the sheath 3 has amatching shape, by means of which the sliding of the sheath 3 onto thecarrier core 2 produces correct positioning of the carrier core 2 andthe sheath 3 relative to each other and the contact elements 4 alwayscome to rest against the connecting lips 9 of the contacts 8.

FIGS. 4 and 5 show an alternative embodiment of the invention. In thiscase the electrode has an elongated carrier 16 which is provided with apart 17 with a shape which is adapted to the body orifice and a handle18 connecting thereto. In this case use is made of a sheath 19 of a thinflexible material, which in FIG. 4 for the sake of clarity is showngreatly exaggerated at a great distance from the carrier 16, but inpractice can lie in a more close-fitting manner around said carrier 16.Recesses 20 for receiving loose contacts 21 are formed in the part 17 ofthe carrier 16; four of said recesses are again present, and only onecan be seen in FIG. 4. Contact elements 22, which are slidable to andfro in the axial direction by means of a button 23, are fitted in thecarrier 16. These contact elements 22 are in turn connected, in a mannernot shown, to a connector 24 fitted at one end of the carrier 16.

Before use, a sheath 19 is fitted over the carrier 16 and four contacts21 are pressed into the recesses 20 of the carrier 16. Each contact 21here has a contact end 25 which pierces through the sheath and is lockedon the contact element 22. The sheath 19 is held fast in a sealingmanner between the contact 21 and the recesses 20 of the carrier 16, sothat the carrier 16 remains insulated from the environment. After use,the contacts 21 can be released again by withdrawing the contactelements 22 with the button 23.

It is pointed out that the contacts 8, 21 in the embodiments describedare strip-shaped and are fitted in the axial direction of the electrode.This ensures that even without accurate positioning of the electrode inthe body cavity good positioning relative to the sphincters is achieved.It is, however, also possible to use annular or partially annularelectrodes.

The shape adapted to the body orifice also means that the electroderemains in place despite any muscle contractions.

Although the above describes an electrode for use in the vagina forstimulating or detecting muscle activity of the sphincter of the urethrafeminina, the electrode according to the invention with a suitableshaping can also be used for treatment of the sphincter ani. Put in moregeneral terms, the electrode is suitable for stimulating and/ordetecting muscles or muscle groups which are accessible through a bodyorifice such as, for example, the pelvic floor muscles of a woman.

It can be seen from the above that an electrode is provided with acarrier 2, 16 which is suitable for multiple use, and a sheath 3, 19which is discarded with the contacts 8, 21 after use. These parts arevery simple in design and can be mass-produced at low cost. This meansthat the electrode described in both embodiments is very suitable forthe treatment of patients with incontinence problems, in which case, onthe one hand, stimulation of the muscle activity can take place and, onthe other, the muscle activity of the muscles or muscle groups, such asthe pelvic floor muscles, can be detected. After use, the disposablepart 3, 8 or 19, 21 can be thrown away, so that no disinfection orsterilization of the electrode is necessary.

The invention is not limited to the examples of embodiments describedabove, which can be modified in various ways within the scope of theinvention.

I claim:
 1. An electrode assembly for stimulating and/or detectingmuscle activity of a muscle or muscle groups accessible through a bodyorifice, which comprises:a carrier member having contact elementselectrically connected to a stimulation and/or detecting assembly; andan elongated sheath member formed of a rigid insulating material andhaving a handle portion and an insertion portion shaped to said bodyorifice, said insertion portion having electrical contact elementsincluding contact lips extending outwardly from said insertion portion,said elongated sheath member positioned on said carrier member wherebysaid contact lips are caused to be in electrical contact with saidcontact elements of said carrier member, said contact lips projectradially into said sheath member and are resiliently supported in anaxial direction against said contact elements of said carrier member. 2.The electrode assembly as defined in claim 1 and further includingcomplimentary positioning elements formed on said carrier member andsaid elongated sheath member.
 3. The electrode assembly as defined inclaims 1 or 2 wherein said elongated sheath member is comprised ofelongated shell half members, one shell half member provided withrecesses for positioning said electrical contact elements, another shellhalf member provided with clamping plates positioned proximate saidrecesses for fixing said electrical contact elements within saidrecesses of said one shell half member.
 4. An electrode assembly forstimulating and/or detecting muscle activity of a muscle or musclegroups accessible through a body orifice, which comprises:an elongatedcarrier member formed of a handle portion and an insertion portion andprovided with slidable contact elements electrically connected to astimulation and/or detecting assembly; an elongated sheath member formedof a flexible insulating material to be positioned about said elongatedcarrier member; and electrical contact members for clamping saidelongated sheath member to said insertion portion of said elongatedcarrier member by engaging said contact elements of said elongatedcarrier member.
 5. The electrode assembly as defined in claim 4 whereinsaid insertion portion of said carrier member is formed with recessesshaped to receive said electrical contact members and said electricalcontact member including contact ends for engaging a respective contactelement.
 6. The electrode assembly as defined in claim 4 or 5 wherein anend of said handle portion of said elongated carrier member remote fromsaid insertion portion thereof is provided with conductors to provideelectrical connection to said stimulating and/or detecting assembly. 7.The electrode assembly as defined in claims 4 or 5 wherein saidelectrical members are strip-shaped and positioned axially about saidsheath member.